MAUDE Adverse Event Report: SPECTRANETICS CORPORATION TIGHTRAIL ROTATING DILATOR SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	545-511
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation of Vessels (2135); Pericardial Effusion (3271)
Date of Event	04/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A lead extraction procedure commenced to remove a right ventricular (rv) and right atrial (ra) lead due to bacteremia with thrombus.Spectranetics lld ez lead locking devices (lld ezs) were inserted into each lead to provide traction.Beginning with a spectranetics 16f glidelight laser sheath and spectranetics visisheath dilator sheath on the ra lead, progress past the clavicle was unsuccessful.Switching to a spectranetics 11f tightrail sub-c rotating dilator sheath, advancement was made up to the innominate and had to utilize a spectranetics 11f tightrail rotating dilator sheath (long) to remain coaxial on the lead.Reaching the superior vena cava (svc)/ra junction, the ra lead freed from the heart and was removed.However, the patient's blood pressure dropped, and a pericardial effusion was detected via transesophageal echocardiogram (tee).Rescue efforts began, including rescue balloon, pericardiocentesis, and thoracotomy.A perforation in the ra (mdr #3007284006-2025-00091) and a small perforation in the innominate were discovered and repaired.The remaining rv lead was removed post-thoracotomy, and the patient survived the procedure.This report captures the 11f tightrail device in use when the innominate perforation occurred, requiring intervention.There was no alleged malfunction of any spectranetics devices in use during the procedure.
Additional Manufacturer Narrative
B7) other relevant history, including preexisting medical conditions - not available from facility.H3) the tightrail was discarded, thus no returned product investigation was performed.H6) perforation of vessels is a known risk of complication with use of the tightrail device.Submission of this report does not, in itself, represent a conclusion by the manufacturer and/or authorized representative or the national competent authority that the content of this report is complete or accurate, that the medical device(s) listed failed in any manner and/or that the medical device(s) caused or contributed to an alleged death or deterioration in the state of the health of any person.

• Brand Name: TIGHTRAIL ROTATING DILATOR SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer (Section G): SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: nicole worford ; 9965 federal drive; colorado springs, CO 80921 ; 719447-2465
• MDR Report Key: 21995413
• Report Number: 3007284006-2025-00090
• Device Sequence Number: 19911409
• Product Code: DRE
• UDI-Device Identifier: 00813132021641
• UDI-Public: (01)00813132021641(17)270325(10)0303439571
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150360
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 545-511
• Device Catalogue Number: 545-511
• Device Lot Number: 0303439571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPECTRANETICS 11F TIGHTRAIL SUB-C DILATOR SHEATH; SPECTRANETICS 16F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM; SPECTRANETICS LLD EZ LEAD LOCKING DEVICES; SPECTRANETICS VISISHEATH DILATOR SHEATH; ST. JUDE MEDICAL 1581 RV PACING LEAD; ST. JUDE MEDICAL 1688TC RA PACING LEAD
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 44 YR
• Patient Sex: Male